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OpenTrials
Completed

NCT Number: NCT04700462

COVID-19 Preventive Behavior in African Americans

The Center Disease Control has published a set of guidelines to contain the spread of the virus, since it is known to spread from person-to-person. Given the vaccine and specific antiviral treatment for Coronavirus disease (COVID-19) remain under development and will take months or years to develop, intermittent and sustained preventive behaviors may be needed into 2022 unless effective treatments or vaccines are developed. Thus, effectively implementing preventive behaviors remains a critical step in bringing the pandemic under long-term control. Leveraging the ecological momentary assessment (EMA) method developed in the parent R01 for smartphones, which allows for real-time data collection on individual's behaviors, the investigators propose a prospective single arm and longitudinal study to examine the effectiveness of self-monitoring EMA (SM-EMA) in promoting adherence to COVID-19 preventative behaviors. SM-EMA users will download the smartphone app which includes: (1) instructional videos to provide knowledge of preventative behaviors; (2) self-monitoring of preventative behaviors during intervention and follow-up phases; (3) tailored-feedback messages to encourage preventative behaviors; and (4) mobile-enabled website to provide an interactive learning platform. If proven efficacious, this intervention could be efficiently disseminated to reach the larger public and foster preventive behaviors into self-management as effective strategies for long-term control of the COVID-19 pandemic.

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Key information

Conditions

Covid19 Behavior COVID-19 Coronaviridae Infections Coronavirus Infections Health Behavior Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

About this study

Given the vaccine and specific antiviral treatment for COVID-19 will take months or years to develop and finalize, preventive behaviors remain the most effective strategy thus far and may be needed until 2022 to control the pandemic. African Americans, who have 3-fold higher infection rate and 6-fold higher death rate compared to the white counterparts, are an especially vulnerable population to COVID-19. Immediately initiating a project that promotes and maximizes adherence to preventative behaviors is vital to addressing the ongoing COVID-19 pandemic. The investigators propose a prospective single arm and longitudinal study to examine the effectiveness of SM-EMA in promoting adherence to COVID-19 preventative behaviors. The intervention will include two daily pop-up messages during Week 1 (one in the morning and one in the afternoon), one daily pop-message in Week 2, and two pop-up messages a week in Weeks 3 and 4. The duration for the intervention will be four weeks. The study outcomes will be collected at baseline (pre-intervention, T1), post-(completion of the intervention, T2, primary endpoint), and monthly follow-up for three months (T3-T5). The total study duration will be four months.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • African American aged 60 or older
  • Able to read and write English
  • Willing to commit to use the smartphone app with the pop-up messages and then four follow-up surveys (total four months).

Exclusion criteria

  • No children or others aged 59 years or younger

Treatment and study plan

Sm-EMA

Behavioral

Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e. COVID-19 preventative behaviors).

Primary outcomes

  1. Change in Knowledge Test score as assessed by a questionnaire

    Time frame: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention

    It is a measure of one's knowledge of COVID-19 preventative behaviors, with a score range of 0-18, higher scores indicating better knowledge.

  2. Change in Self-efficacy as assessed by self-efficacy questionnaire

    Time frame: Pre-intervention, Immediately Post-intervention, 1, 2, and 3 months Post-intervention

    It is a measure of one's belief that they will be successful in reaching a behavior goal, with 6-items of questionnaire, with a score of 0-60, higher score indicating higher level of self-efficacy.

  3. Change in preventive Behavior Score

    Time frame: Pre-intervention, Daily during intervention week 1 and bi-weekly during intervention weeks 3-4, Immediately Post-intervention, 1, 2, and 3 months Post-intervention

    It is a measure of one's adherence to COVID-19 preventative behaviors, with a score range 0-18, higher score indicating worsening preventive behaviors.

  4. Change in System Usability Scale (SUS) score

    Time frame: Immediately Post-intervention

    It is used to assess the global view of the participant's assessment about usability of SM-EMA, with a score of 1-7, higher score indicting more useable for the app.

  5. Change in Global Impression of Change as assessed by a questionnaire

    Time frame: Immediately Post-intervention, 1, 2, and 3 months Post-intervention

    It is a single item used to assess the participant's perceived behavior change, with a score of 1-7, higher score indicating better global impression of change.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 7, 2021
Registry last updated
Nov 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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